Devices, Methods and Systems for Acquiring Medical Diagnostic Information and Provision of Telehealth Services

ABSTRACT

The invention relates generally to various systems, tools and methods for acquiring diagnostic information, including medical information, for a user, transmitting the information to a remote location, assessing the information, and transmitting resulting diagnosis and treatment information to the user and/or a third party for subsequent action. The present invention provides consumer and user-friendly telemedicine systems and procedures which enable health services and/or diagnosis to be provided at a distance remotely.

This application is a continuation of prior, co-pending, U.S. patentapplication Ser. No. 15/920,208, filed on Mar. 13, 2018, which is acontinuation of U.S. patent application Ser. No. 13/929,591, filed onJun. 27, 2013 (now abandoned), which claims the benefit of priority toU.S. Provisional Application No. 61/664,920, filed on Jun. 27, 2012, allof which are incorporated herein by reference in their entirety for allpurposes.

FIELD OF THE INVENTION

The invention relates generally to various systems, tools and methodsfor acquiring diagnostic information, including medical information, fora user, transmitting the information to a remote location, assessing theinformation, and transmitting resulting diagnosis and treatmentinformation to the user and/or a third party for subsequent action. Morespecifically, the present invention relates to consumer anduser-friendly telemedicine systems and procedures which enable healthservices and/or diagnoses to be provided remotely.

BACKGROUND OF THE INVENTION

Currently, patients with an injury or undiagnosed pain are typicallyforced to visit one or more physicians or medical treatment centers tohave their condition diagnosed. If the patient is a small child, or ifthe condition is thought to be serious or in need of immediatetreatment, the long waiting periods for a physician appointment may seemunreasonable or unacceptable, and the patient often ends up going to anemergency room and/or urgent care center on a “walk-in” basis. At themedical facility, the patient (or his/her guardian or caregiver) fillsout medical history forms, answers questions about the condition, andhas a clinician perform a physical examination to learn about thecondition. In many cases, the waiting period at the facility can consumemany hours, depending upon facility capacity and other patient needs(e.g., emergency cases treated as priority, etc.). Ultimately, thepatient's visit may have been unnecessary, as the condition was nottruly “urgent” or “critical,” and thus treatment could have been delayedand/or accommodated at a regularly scheduled appointment, or thecondition would have resolved itself with little or no intervention bythe physician.

In many cases, the stress and uncertainty associated with the patient'scondition can be more debilitating than the condition itself, especiallywhere the patient is a small child, and the caregiver is aninexperienced parent who is anxious about his or her child's condition.Moreover, because emergency treatment centers such as emergency roomsand urgent care centers are operating at or over capacity, the long waittimes at such facilities can further exacerbate stress, leading to awide variety of potential medical situations including hypertension,heart attacks and/or strokes, as well as possible physical and/or mentalaltercations between patients and/or caregivers. Moreover, theunnecessary use of emergency and urgent care facilities levies a heavycost on the nation's health care and health care insurance systems, assuch services are generally much more expensive than similar servicesprovided on a scheduled or appointed basis.

SUMMARY OF THE INVENTION

The various inventions disclosed herein include the identification of aneed for consumer-and/or user-friendly devices that can be employed byuntrained or semi-trained individuals to safely and effectively capture,store, transmit, display, download and/or update medical or otherinformation, including assessments, examinations, and evaluations of apatient's condition via electronic media for use by patients,clinicians, health care providers, and system administrators. Inaccordance with one exemplary embodiment of the present disclosure, themethod includes, without limitation, a non-medical professional (e.g., aconsumer or other patient, etc.) utilizing a device to perform anexamination protocol for a patient's condition, the device having thecapability to store and/or transmit relevant information for use in anasynchronous or other telemedicine environment. The performing of theexamination can include storing information about the patient'scondition in a storage medium, include storage media accessed remotely(e.g., USB accessible, LAN accessible and/or internet accessible storagedevices), as well as localized storage associated with the device (e.g.,RAM or flash memory, SD cards, attached smartphone memory, etc.). Thedevice can simultaneously and/or subsequently upload stored data to ageneral or specialized storage network, or remote access to theelectronic storage medium can be provided over a computer or othercommunication network. The stored data can then be accessed by acompetent medical professional or other caregiver, properly assessed,and recommendations regarding the condition and/or treatment can betransmitted or otherwise given to the patient or guardian.

Various embodiments disclosed herein include the manufacture,distribution and use of specialized and/or generalized devices that canbe utilized by non-medical personnel (e.g., consumers) to collectpatient information in a home-care or non-medical facility location. Theinformation can then be transmitted and/or otherwise accessed byqualified medical and care-giving personnel, and appropriate assessment,condition and/or treatment information can be transmitted or otherwiseprovided to the patient. In various embodiments, the device can be apart of and/or used in conjunction with electronic communications and/ordisplay systems such as telephones, cell phones, smart phones,computers, wireless radios and/or other communications media known inthe art. Desirably, the disclosed systems will allow a patient totransmit sufficient information to the medical professional to enableassessment of the patient's condition, which may include informationrelevant to immediate and/or critical treatment of the condition thatmay not be readily apparent to the patient. In various embodiments, theinventive systems allow trained personnel to direct the patient'sactions and/or use of the diagnostic tools, such as requestinginformation regarding specific anatomical features which may be imagedby the diagnostic device in the hands of the patient as requested “realtime” by the physician.

In various embodiments, the disclosed systems and methods include theability to collect patient information at a plurality of times orconditions, whereby the information can be transmitted and/or otherwiseaccessed by the medical professional and used in the assessment of thepatient's condition. Such information may be stored for various periodsof time, at differing locations, and previously-stored data can betransmitted and/or made available in conjunction with current patientinformation and used in the assessment of the patient's condition.Similarly, patient information collected via other methods, includingroutine physicals and/or during doctor office visits, can be collectedand provided with current patient information in a similar manner. Ifdesired, the specialized and/or generalized consumer device (or otherdevice such as a smartphone or computer) can include memory featuresthat collect and store such information, such as the identity anddosages of medicines currently being taken by the patient or the factthat the patient has diabetes or other medical conditions.

Various alternative embodiments include the provision of aninternet-accessible healthcare system to consumers, whereby the consumercan provide patient information (as previously described) to the system,and can receive assessment, condition and/or treatment information froma healthcare professional associated with the system. In variousembodiments, the system can provide the consumer and/or patient withstatus updates and/or other relevant information during the process to:(1) confirm receipt and/or integrity of the relevant patientinformation, including patient medical data and payment information, ifnecessary, (2) identify various steps of the process, and the patientinformation's current status (e.g., data assigned to a physician orspecialist, data currently being reviewed, medical recommendations beingprepared, system scheduling a local physician visit on patient's behalf,system directing patient to a local emergency room, system dispatches anambulance or paramedics to the patient's location, etc.), (3) requestadditional information from the patient (either using the current deviceand/or additional devices, some of which may be immediately available tothe patient) which may include initiating a live-call or othercommunication between the medical professional and the patient, (4)providing assessment, treatment and/or other information to the patient,and (5) forwarding prescription or other treatment information to thepatient, hospital, pharmacy or other care-giver as requested by thepatient and/or assigned by the system. In various embodiments, theprovision of the type of updates can significantly reduce patientanxiety while waiting for treatment information, as well as confirm tothe patient whether the patient information has been received and/or isbeing reviewed by the system. In addition, in situations where thepatient is unable or unwilling to access emergency services directly(e.g., the patient is stuck in an accident on the road, lost in thewildness, climbing a mountain, located in a collapsed building, etc.),the present system and methods described herein can provide criticalcare data directly to the patient, as well as provide emergency responsepersonnel with detailed information about a patient's condition, thatmay take mere seconds for the device to collect, allowing responders toprioritize their response and/or equip themselves for specializedmedical responses.

In various embodiments, the present system can be associated withvarious healthcare-providing organizations and/or payors, includingclinics, hospitals, insurance companies, employers and/or governmentalentities, as necessary and/or allowed by current or future laws (e.g.,privacy and health care information accessibility statutes, etc). Theuse of such systems by such entities can significantly reduce congestionof existing emergency as well as non-emergency health services (byreducing the number and/or frequency of unnecessary patient visits) aswell as significantly improve the provision of health care to thegeneral consuming population in a highly effective and cost-efficientmanner. Moreover, various embodiments of the system can significantlyreduce the need for medical professionals to be located proximate totheir patients, and can even promote and/or encourage “time shifting” ofmedical care by patients and/or medical professionals.

Various technical features of the invention generally relate to devices,systems and methods that facilitate remote connection and communicationbetween two or more parties for medical, health and/or wellnesspurposes, herein collectively referred to as telehealth. In variousembodiments, technical features are disclosed that generally relate todevices, systems and methods for capturing, displaying, recording and/ortransmitting diagnostic information, including remote controlmanipulation of devices and/or diagnostic information. Other technicalfeatures of the invention generally relate to devices, systems andmethods that provide the infrastructure, logistics and user interfacesto make possible remote or at home diagnosis, advice and/or coaching formedical, health and/or wellness purposes (herein collectively referredto as health purposes). Other technical features of the inventiongenerally relate to devices, systems and methods providing advancedfeatures for a more pleasurable user experience and/or more elaboratetelehealth system.

In various embodiments, the systems and methods disclosed herein canfacilitate one or more of the following (including various combinationsthereof):

A. Reduction of health care costs for both payer and patient/consumer;

B. Providing adequate patient access to primary care physicians. Theinvention desirably accommodates reducing the number of primary carephysicians and increasing the number of patients able to be served;

C. Early diagnosis focusing to help minimize disease progression;

D. Accommodation of modern fast-paced life/culture. Moderncommunications methods and widespread internet/wireless connections havecreated consumers' expectations for more convenient and more rapidanswers and access to information, including 24-hour and/or “real time”access to services;

E. Consumer-friendly and/or ruggedized information capture devices: Theinvention provides access to telemedicine and creates a need for theability to capture diagnostic information remotely; and

F. Reduction of the number of high-cost visits to an emergency room orfacility/urgent care.

In various alternative embodiments, similar systems and methods asdescribed herein could have varying levels of utility in non-health careapplications, including the collection of relevant data using similardevices and/or the provision of “expert” advice for various otherpurposes, including non-medical diagnostics such as carpentry, plumbing,auto repair, etc.

It is to be understood that a reference to an individual encompassessingular and plural instances of the individual. For example, a medicalcare professional or provider may be a single person providing medicalcare, or multiple individuals working in concert to providecomplementary service(s) to the patient or caregiver. Similarly, acaregiver can be a single individual such as a parent, or multipleindividuals such as attendants at a nursing home.

In certain instances herein, components of the invention mayalternatively be referred to as elements. These terms, as well as othercomparable terms, are to be considered as interchangeable.

An embodiment of one aspect of the present invention is directed to animaging apparatus for obtaining images inside a patient's ear canal. Theimaging apparatus according to this embodiment comprises a main body andan extension having a central axis structurally configured for insertioninto the patient's ear canal. The imaging apparatus comprises an imagingelement for obtaining images which are angled and/or offset relative tothe central axis of the extension into the ear canal. Alternatively, theimaging apparatus may be configured to obtain images in line with thecentral axis of the extension but where the extension is offset and/orangled relative to the ear canal central axis. Further, the imagingapparatus may obtain images which are angled and/or offset relative tothe central axis of the extension and angled and/or offset relative tothe central axis of the ear canal. The main body and/or extension mayengage with the outer ear or ear canal to encourage these positions.

The imaging apparatus may comprise an engagement member which isstructurally configured to be supported in-use by a patient's ear orhead so that the user, provider, or caregiver does not need to supportor hold the apparatus in position.

The imaging apparatus may comprise a wireless transmission element forwirelessly transmitting the obtained images to a processing or computingdevice. Alternatively, the imaging apparatus may communicate with aprocessing or computing device via a wired connection. A non-limitinglist of examples of computing devices include mobile telephones,smartphones, laptop computers, tablet computers, desktop computers,servers, mainframes, and dedicated hardware computing devices. Thesedevices can operate using mobile operating systems such as iOS (fromApple Inc.) and Android (from Google Inc.), desktop operating systemssuch as OSX (from Apple Inc.) and Windows (from Microsoft Corp.), or anyother kind of operating system or platform. The computing device canalso be custom-designed and manufactured for use specifically with theimaging apparatus.

The extension portion of the imaging apparatus may have a soft outersurface for improved patient comfort during insertion of the extensioninto the patient's ear canal.

An embodiment of another aspect of the present invention is directed toan oral imaging apparatus in the shape of a pacifier. The imagingapparatus may comprise an imaging element configured for taking an imageof the oral cavity of a patient; and a transmission element fortransmitting the image to a processing or computing device.

An embodiment of another aspect of the present invention is directed toa kit for collecting diagnostic information of a patient. Althoughdifferent embodiments of the kit may contain different components, auseful combination comprises a main body and one or more attachments.The main body comprises diagnostic equipment, such as processing and/orcomputing elements, for obtaining medical diagnostic information of thepatient, and a transmission element for transmitting the diagnosticinformation via wired or wireless connection to a computing device.

A useful first attachment for the main body comprises an imaging elementstructurally configured for imaging the ear canal and/or the ear drum ofthe patient. A useful second attachment for the main body comprises animaging element structurally configured for imaging the oral cavityand/or throat of the patient. The kit may also comprise a thirdattachment having a sound accessing element structurally configured toobtain internal sounds of the patient's body. The kit may comprise anycombination of first and/or second and/or third attachments.

The transmission element in the kit may be configured to transmit thediagnostic information in real time as the device is in use, or thediagnostic information may be transmitted upon receipt of an instructionfrom a user or provider. The transmission element may have thecapability of transmitting the diagnostic information in a plurality ofimage resolutions, image sizes, or transmission speeds, or combinationsthereof. For example, the transmission element can be configured to sendimages at VGA, SVGA, HVGA, or another resolution, or video at 12 framesper second, 24 frames per second, or another frame rate.

Any of the components of the kit such as the main body may bestructurally configured as a hands-free unit while in-use, or as ahandheld unit while in-use.

Another aspect of the present invention provides for a method ofremotely providing medical information to a patient by a health careprofessional. The method may comprise the steps of:

a. providing, via a remote connection, the patient's current medicaldata to the health care professional;

b. optionally providing the health care professional with the patient'smedical history;

c. causing the health care profession to develop an assessment of thepatient's current physical condition on the basis of the current medicaldata and the medical history if available; and

d. communicating the assessment to the patient or patient's caregiverover an electronic communications channel.

The method may also include providing, by the health care professional,the patient or patient's caregiver with treatment information. Thetreatment instructions can include any kind of medical advice orinstructions, such as providing the patient with a prescription for adrug or a laboratory procedure; directions to visit a medical careprovider, pharmacy, hospital, or laboratory. Multiple instructions canalso be given to multiple parties. For example, the health careprofessional can provide (a) the patient's caregiver with verbal medicalcare instructions; (b) a pharmacy with a prescription for filling; and(c) a laboratory with advance notice that the patient will need acertain kind of test to be performed.

Another aspect of the present invention is directed to a method ofremotely providing medical information by a health care provider to apatient. The method may comprise the steps of:

a. providing, via a remote connection, instructions to an untrained orsemi-trained consumer to perform an examination protocol for a patient'scondition using an examination device which stores and/or transmitscurrent patient medical data for use in an asynchronous or telemedicineenvironment;

b. transmitting, by the consumer, the examination protocol data to thehealth care provider;

c. causing the healthcare provider to develop an assessment of thepatient's current physical condition on the basis of the data obtainedby the examination device; and

d. communicating the assessment to the patient or the patient'scaregiver over the remote connection.

The method may further comprise providing, by the health careprofessional, the patient or patient's caregiver with treatmentinformation for the patient.

The examination protocol data can be transmitted to the health careprovider in real time, as the data is acquired, or not in real time, forexample, upon receipt of an instruction or request from the provider orhealth care professional for this data. In such embodiments, theexamination protocol data can be stored in a storage medium such as aflash drive in a device participating in the performance of theinvention.

An embodiment of another aspect of the present invention is directed toan examination device for performing an examination protocol for apatient's condition. The examination device can comprise:

a. an anatomical interface structurally configured for application to apredetermined area of the patient's body;

b. an accessing and capturing component which obtains current medicaldata of the patient after application of the anatomical interface to thepatient's body;

c. a diagnostic processing component which processes the medical dataobtained by the accessing and capturing component; and

d. a communications link over which the processed medical data istransmitted to a communications component for viewing and interpretationby a medical care provider.

The anatomical interface is structurally configured for application tothe patient's ear, nose, throat, eye, wrist, skin, head, skin,extremities, torso, or into a body orifice such as the inside of themouth or nose. In this manner, the anatomical interface of the devicewill facilitate providing accurate patient medical status information.

Any of the disclosed devices, systems, or components may comprises aremote control component which is structurally configured to respond tocontrol signals sent remotely by the medical care provider or acaregiver over a communications link. The communications link cantransmit the obtained medical data in the form of still images, a videofeed, an audio feed, a data stream, or a combination thereof, to themedical care provider.

Any of the disclosed devices, systems, or components may comprises aport or jack configured for attachment to a computing device such as amobile telephone, laptop computer, tablet computer, or desktop computer.The port or jack may be conventional such as a minijack, USB port, AppleiDevice port (such as an iPhone or iPad), or custom-designed by themanufacturer.

Examples of the accessing and capturing component of the presentinvention include a mobile telephone, laptop computer, tablet computer,desktop computer, or a custom-designed hardware element.

Examples of the diagnostic processing component of the present inventioninclude a mobile telephone, laptop computer, tablet computer, desktopcomputer, or a custom-designed hardware element. In certain embodimentsof the invention, the accessing and capturing component and thediagnostic processing component can be the same hardware element. Thatis, the hardware element can have multiple functions as discussed andprovided in this specification.

An embodiment of another aspect of the present invention is directed toa telehealth system for remote diagnosis of a patient's medicalcondition. The telehealth system can comprise elements such as:

A. a user subsystem configured for receiving a patient's current medicaldata, the user subsystem comprising:

-   -   1. a communication device;    -   2. a diagnostic processing device; and    -   3. a diagnostic capture device;

B. a provider subsystem configured for communicating with a health careprovider, the provider subsystem comprising:

-   -   1. a communication device; and

C. an infrastructure subsystem configured to process and store medicaldata and diagnostic information received from the user subsystem and theprovider subsystem, the instrastructure subsystem comprising:

-   -   1. an application server comprising computer instruction code        configured to communication with:        -   a. a database configured to store a patient's personal            information and electronic health record;        -   b. diagnostic computer instruction code configured to            receive current patient medical information and to provide            diagnostic information concerning the patient's medical            condition; and        -   c. a database configured to store archived diagnostic            information;    -   2. a server comprising computer instruction code configured to        communicate with one or more third-party patient personal        information or electronic health record databases; and    -   3. a server comprising computer instruction code configured to        communicate with a third party telehealth system,

wherein the user, provider, and infrastructure subsystems arestructurally configured to communicate information over an electronicdata network.

Definitions

For convenience, further information regarding the following terms isprovided below. Other and equivalent terms in this description may beused to describe similar concepts.

Patient: One or more individuals desiring or needing health advice. Amay be a group, e.g. exercise class or sport team.

Caregiver: One or more individual(s) that assist the patient with theirhealth concern. This individual is usually known to the patient, e.g. ason or daughter or parent or coach.

User: One or more patient(s) and/or caregiver(s).

Health Professional: Any individual certified or experienced within ahealth related field. Examples include a physician, surgeon, nurse,physician assistant (PA), nurse practitioner (NP), physical therapist,nutritional expert, paramedic etc, medic, paramedic, EMT, etc.

Nurse Hotline: A service provided by an insurance company or healthrelated entity that provides health advice or helps connect anindividual with the appropriate health professional.

Call Center: A service, that may be provided by a non-health relatedentity, that provides health advice or helps connect an individual withthe appropriate health professional.

Provider: One or more health professional(s), nurse hotline and/or callcenter.

Description of Various Exemplary Embodiments

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention, which may be embodiedin a manner not expressly described. While the preferred embodiment hasbeen described, the details may be changed without departing from theinvention, which is defined by the various disclosures and claimsprovided herein.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 illustrate exemplary embodiments of a telehealth system inuse.

FIG. 3 illustrates linked components of an exemplary embodiment of atelehealth system.

FIG. 4 illustrates three components of a telehealth system in accordancewith an exemplary embodiment of the invention;

FIGS. 5-7 illustrate exemplary embodiments of user devices structurallyconfigured for insertion into the human ear which communicate apatient's current medical status in accordance with the presentinvention.

FIGS. 8 and 9 show a cross-section of the ear region of a patient's headfor purposes of reference.

FIGS. 10-20 illustrate exemplary embodiments of an ear imaging devicecomprising an anatomical interface to facilitate positioning and imagequality and may also serve as safety mechanisms that prevent overinsertion.

FIG. 21 illustrates features of the outer human ear for purposes ofreference.

FIGS. 22-24 illustrate exemplary embodiments of an over-ear device forobtaining a patient's current medical status.

FIGS. 25 and 26A-D illustrate exemplary embodiments of an over-eardevice and different configurations of the outer ear elements.

FIGS. 27 and 28A-F illustrate side and bottom views of an exemplary earimaging device.

FIGS. 29 and 30 illustrate exemplary embodiments of anatomicalinterfaces for an medical device for insertion into a patient's mouth orear.

FIG. 31 illustrates an exemplary embodiment of a medical diagnosticinstrument equipped with a microphone.

FIGS. 32-35 illustrate exemplary embodiments of medical diagnosticinstruments for collection of patient medical information.

FIGS. 36-37 illustrate exemplary embodiments of kits comprising devicesfor accessing, capturing, and at least partial processing of medicaldiagnostic information in accordance with the present invention.

FIGS. 38A-38E illustrate exemplary embodiments of medical diagnosticdevices in accordance with the present invention which are structurallyconfigured to be placed on, in, or adjacent to a patient's body forobtaining medical diagnostic information.

DETAILED DESCRIPTION

I. Telehealth System: An Overview

The various figures described herein depict a variety of telehealthand/or other systems for remote diagnosis of health concerns. It shouldbe understood that, while these exemplary systems include many differentelements, which will be described in the sections that follow, variousother embodiments of such system(s) may also include additional or fewerelements, as desired by the user and contemplated by the presentdisclosure. Some of these simpler or more complex systems will bediscussed later.

Communication Component and Remotely Linking One or More User(s) and/orProvider(s).

A telehealth system will preferably include a method to remotely linkone or more parties through communication devices and enable voice,video and/or text communication. Alternatively, a system may employcommunication devices to allow a user to record and/or upload video,voice, text, background health information and/or diagnostic informationand enable a provider to evaluate and provide a diagnosis or advicewithout live communication with the user.

The communication component(s) may take a variety of forms. For example,the user may communicate with a computer, a tablet, a landline phone, astandard mobile phone, a smart phone such as the Apple iPhone, a uniquecommunication device specialized for use with a telehealth system, orany other device that allows recording, transmission and/or uploading ofvoice, video, text, files and/or diagnostic information. In variousembodiments, the device will desirably allow receiving of similarinformation and enable the user to receive a diagnosis or advice fromthe provider. The provider communication component is of similar designand capability. Desirably, the provider communication device will beable to receive information from the user and transmit a diagnosis oradvice to the user. The user and/or provider may use more than onecommunication device concurrently or sequentially. For example, a usermay use a landline phone to communicate by voice with a provider and usea computer to receive and transmit diagnostic information. While thedevice that transmits diagnostic information may also have (or may be) acommunication device, it will also be described as a diagnosticprocessor, which may be separate from the communication device(s).

The link between the user and provider may be created using a variety ofmethods. A user(s) can initiate a telehealth session by submitting arequest for care. This request may be directed to a specific provider(for example, the patient's primary care physician), a limited networkof providers, or it may be “crowd sourced” to any available provider,which may facilitate a more instantaneous response. In addition, therequest may be routed to a nurse hotline or call center that may providea preliminary evaluation and as necessary forward the connection to anappropriate provider.

A provider then accepts the request for care and in various embodimentsa secure link between the user(s) and the provider(s) can beestablished. This link may be as simple as a phone call but moredesirably includes a video link between the user(s) and provider(s).Also, as previously stated, the secure link may only involve thetransmission of information (e.g. video, voice and/or diagnosticinformation) and not require “real time” live communication. Thediagnostic information and/or other information such as a recorded voiceand video transmission may be reviewed by a provider and/or softwareanalysis tool offline from the user and a diagnosis or advice forwardedto the user.

Collecting and Transmitting Diagnostic Information and Relevant MedicalHistory

The provider(s) then collect and/or review the relevant health historyfrom the user(s) and a description of the health issue that the user(s)requires help for. If some or all of this information is contained inthe user's account or in some pre-loaded form in a remote location, theuser may elect to directly share this information with and/or authorizerelease of this stored date to the provider(s). In addition, it may bedesirable that the user is able to share up-to-date (current) diagnosticinformation with the provider. This information may have been collectedrecently, over time, or during the call through the use of various homediagnostic devices. Examples of patient information can include bloodpressure readings or blood glucose levels. These devices may provide thedata only to the user, and the user can then share this data with theprovider or allow the data to be sent or shared directly with theprovider through a communication channel. This diagnostic informationmay also be collected through the use of diagnostic devices described inthis document. Ideally, the diagnostic device is connected to acommunication channel which gives the provider one or more feeds of thediagnostic data and when applicable the ability to control or refinediagnostic feeds or download snapshots or segments to allow highresolution or more precise information to be viewed. Relevant healthhistory information may also include information or data stored orotherwise obtained from the diagnostic device or a linked device, suchas geographic location data from a smartphone GPS and/or credit card orpayment information from an electronic wallet, etc.

The next step is for the provider to determine a diagnosis or giveadvice to the user. This may include an e-prescription (which mayinclude directions to a local pharmacy identified using GPS geographicinformation from the user), scheduling a follow-up consultation and/orrecommending the user proceed to a doctor's office, urgent care oremergency room (which may include directions to a local service providerbased on the patient's location). The user and provider then agree thata sufficient resolution has been reached. A third party may be contactedto help reach a satisfactory outcome if there is disagreement on theresolution.

C. Accounts, Logistics and Infrastructure

The final step of patient care under this exemplary system can involvetermination of the consultation (e.g. provision of patient careinstructions) and completion of logistics. This may include submissionof an e-prescription for patient collection, processing of payment,electronic links to or emails containing the details or summary of thecall, and/or creation and submission of insurance forms or other formaldocumentation.

In various embodiments, it may be preferred that one or more useraccounts of some type are created prior to the initiation of thecommunication. Desirably, a user account should contain sufficientinformation to verify that the patient or other responsible person isable to pay for access to a provider. This account may be anonymous innature, containing as little as payment information only, or may containdetailed information on patient history and/or a link to a patient'sElectronic Health Record (EHR). Desirably, the provider account shouldcontain sufficient information to ensure his/her identity and expertisein order to provide the requested care. This account may be part of alarger account established and maintained by a physician group, aninsurance company, or other similar responsible group.

Telehealth Systems and Additional Features

There are several types of systems and features which may beincorporated into a telehealth system. The telehealth system may be assimple as a phone call between a user and a provider, or includevideoconferencing and live transmission of diagnostic data such asimages being captured by the user with a device. The system may alsoallow text and file sharing as well as links and updates to a patient'selectronic health record (EHR). The provider may simply give advice orprovide a formal diagnosis and submit an e-prescription. The system mayalso incorporate computer analysis of diagnostic data to give the userprobabilities of certain conditions or be used by a provider for a morethorough analysis.

Multiple types of connections will be described, including the abilityto connect a caregiver at one location, a patient at a second locationand one or more providers on the same “call”. The user may selectspecific physicians based on a ranking and pay appropriately, or offer aspecific amount of money and wait for a provider to accept the fee.There may also be social/gaming/educational elements built into thesystem. For instance, users may wish to “crowd-source” their healthissues for comments and advice from other users. Users may be offereddiscounts for achieving a certain level of accuracy in their feedback toother users. The system may include video-game type three-dimensionaltours through or around the body with examples of health ailments andways to prevent or treat these issues. Users may be given points andincrease their status based on correct guesses for exemplary healthailments.

Several embodiments of devices, methods and systems which helpfacilitate the described telehealth system as well as simpler and morecomplex systems are described herein. It should be noted that thatdiagnostic embodiments may be used without a telehealth system, and thattelehealth embodiments may be utilized without the use of diagnosticdevices.

II. Communication Devices, Systems and Methods

Communication Component

Patient/caregiver communication devices can have any kind of structure,and can include devices which allow connection to a distant location,ideally allowing video, text, file sharing and/or other data connection.A plurality of communication devices can also be used in tandem. Forexample, one communication device may be used for video/voicecommunication, and a second communication device may be used as achannel to display and/or transmit diagnostic information to the medicalservices provider. Also, users may be more comfortable speaking over alandline but can see the provider on their computer (a communicationdevice) which also serves as the data diagnostic processing unit totransfer data to the medical services provider. Examples ofcommunications devices are provided below, and they may be used alone orin combination with other communication devices:

landline telephone, which can be used for a simple phone call or with adiagnostic device with wireless/wifi capability or other internetconnection which connects to a conference call with, and feedsinformation to, the provider. A user can also use a landline phone witha computing device to provide video capability;

mobile telephone;

computer and telephone;

tablet and telephone;

tablet only;

computer only (with a standalone diagnostic device as applicable);

supplied device specifically for communicating with this system. Suchdevices are ideally suited for the elderly and they may also serve asthe diagnostic computer. The device may be connected cellularly, have RFor other wireless transmission mode for connection to the Internet or toa base station connected to internet or wireless; and

monitoring device or system set up in a bedroom having wide view or zoomcapabilities, which may be initiated by a caregiver (e.g. for elderlypatients). The system may comprise one or more cameras located in one ormore rooms of the house. Users may be connected to these communicationdevices in a variety of ways. One way, especially useful in case of anurgent issue, is a push button device worn on the body (such as a watch,bracelet, or necklace).

Examples of a provider's communication device include:

telephone only (landline);

telephone and computing device for video or other data connection;

mobile phone only;

tablet only;

computer only;

video conference room; and

simultaneous feeds to other providers for training or additionalphysician (e.g. a specialist)

A communication device preferably has software providing a userinterface to facilitate communication, user experience, transfer ofdiagnostic information, recording, output/display and/or other featuresto aid in the telehealth service.

A communication device may also serve as a diagnostic processor (whichwill be explained in more detail later). This device may outputdiagnostic information (e.g. display images) and transfer the diagnosticinformation to the provider. When used in this fashion, the device mayswitch from video/voice communication to a voice call only whilecollecting and transmitting diagnostic information.

B. Systems and Methods for Remote Linking of One or More Parties

A connection between patient/caregiver and provider(s) may include anyof the following steps, which may be performed in any order:

1. Request connection time, for example, as soon as possible whilewaiting, request first available appointment, request appointment atspecific time or within window of date or time;

2. Select preferred provider (e.g. primary care physician);

3. Select preferred group (e.g. primary care and associates). Groups ofmedical practitioners may be available for selection, or a consumer maybe able to select several individual physicians;

4. Select crowd source option, e.g., for instantaneous access, or forfirst to respond;

5. Select tier base of providers, wherein users pay more for highercredentials or higher ranked providers;

6. Select tiered approach for provider selection. For example, if theprimary care physician is not available, the request for medical carewill then pass to the next larger group after a predetermined timeperiod, then to associates, then crowd sourced;

7. Triage by an instant connection with a nurse hotline, and then routedto appropriate provider (e.g., physician assistant, nurse practitioner,primary care, pediatrician, dermatologist, etc.);

8. Call center to answer and route call;

9. Emergency/distress request. This urgent request for assistance may beinitiated with a panic button or a device worn on the body with adistress button. This button initiates a call and/or enables videodevices in the area of the user. The button may also directly contact911 services or other emergency response services. Upon initiation, thesystem may automatically collect data, download relevant information(e.g., GPS location information, current medical conditions such asdiabetes, or current medication and prescription information) and/ormaintain connection/control by remote user (e.g., medical personnel orpolice) throughout the entirety of the call to monitor the emergencysituation and/or provide assistance;

Any of these options may be first initiated by a caregiver, and then thepatient can be linked to the communication.

A connection between a caregiver and a patient may be received in anynumber of ways. For example, there may be a request from a patient toone or more caregivers. A request could be sent out to a single person,a few select people, or to many caregivers. Alternatively, there may bea request from a caregiver to a patient. The caregiver could open avideo or communication connection without the need for the patient to“answer”. For example, the care giver can activate multi-room cameras ora camera in the bedroom or a bedside device.

User Interface and Software

A provider or other party can be provided with the ability to remotelyselect snapshots or a short segment of video feed (or other type ofdiagnostic data such as sound) for high resolution download.

The user interface of the present invention allows for a simple and fastmethod of establishing a connection with a provider in the user'spreferred method (e.g. crowd-sourced or only to primary care physician,etc., as discussed earlier). This software may be part of a standalonesystem or the software may provide an interface for the user which linkswith third-party telehealth services. This option may be especiallyuseful when the user's insurance company already has a contract with atelehealth service but the user (and may be the insurance company aswell) desires the use of diagnostic devices described herein. The userinterface would establish the easiest and clearest way for the user tomanage the call and diagnostic devices while still using the third-partytelehealth system as the “backbone” of the communication.

III. Diagnostic Devices, Systems and Methods

This section focuses on the different techniques used to gatherdiagnostic information, such as imaging and sound, as well as devicesthat incorporate these methods and, which interface with the humananatomy to allow reliable data capture; and connecting these devices todiagnostic processing components to transmit, output, record and/orupload the data and techniques used to manipulate or remotely controlthe data and/or device for higher quality and/or more efficient viewingof data which may allow a more accurate diagnosis. Diagnostic devicesmay be fully or partially composed of one or more features discussed inthis section, including: 1) accessing and capturing components, 2)anatomical interfaces and 3) diagnostic processing components. Forexample, a diagnostic device may incorporate a lens and fiber optics(accessing) which channel images to a video chip (capturing) which areencapsulated within a thermoplastic shape which fits into the ear canal(anatomical interface) and attaches to a small external ear componentwhich records images and sends the information via BlueTooth®(diagnostic processing) to a smart phone for display, recording andtransfer to the internet (diagnostic processing). In this example, thesmart phone may also be used as the communication component.

Diagnostic Information

Various types of diagnostic information may be desired to help provide aprovider give a diagnosis or medical advice to a user. For example, auser may be concerned that his or her child has an ear infection. Theprovider may desire images of the ear drum, body temperature and medicalhistory. In this case, a light sensor (e.g. CCD or CMOS video chip) maybe used to image the ear drum. A standard thermometer or a device with atemperature sensor may be used to record the body temperature andtransmit the data to the provider.

Another example of an illness where telehealth systems may be helpful isan upper respiratory infection. In this case, the provider may wish toknow how the upper airway and/or oral cavity appears, as well as obtainlung sounds and heart rate. A device with a light sensor may be used tocollect images from the upper airway and a device with a microphone maybe used to listen to lung sounds as well as the heart rate. Thisinformation may then be transmitted live to a provider or uploaded forreview at a separate time by a provider. The medical test data ordiagnosis information may be stored locally by the user, by the medicalpractitioner, or by the medical care facility. The data may also betransmitted to a medical data storage location, or saved in the cloud asis known in the art.

Various other potential ailments may be evaluated. For example, imagesof the skin may be useful for diagnosing rashes, skin cancer or poisonivy. Images of the eye may be collected for eye problems such as red eyeor foreign bodies. Images inside the nose may be useful for evaluatingpotential allergies or nasal infections. Sounds of the knee joint orother musculoskeletal areas may be recorded to help diagnosis arthritisor other ailments.

As will be discussed, a multitude of other data types (light, sound,electrical, temperature, strain, etc.) may be useful to examine anindividual for an untold number of potential ailments.

Accessing and Capturing Diagnostic Data

Capturing devices can include a data capturing element such as amicrophone or light sensor (i.e. CMOS or CCD chip). Examples ofcapturing devices include commercially-available and standardoff-the-shelf devices as well as specialty devices. Examples of standarddevices are those which may readily purchased from vendors and includesmart phones, tablets and computers. Specialty devices are devices builtor supplied specifically for purposes of the invention as describedherein or supplied by other vendors for purposes similar to thatdescribed herein. Examples of specialty devices include devices whichare similar in form to a smart phone as well devices which areincorporated into an anatomical interface and/or processing unit, whichwill be described in further detail later. Examples include speakersincorporated into a belt, similar in form to a heart rate monitor, and avideo chip incorporated into an earphone device that is similar to anearbud or a device that includes an over ear retaining piece.

Imaging

Accessing and capturing light for displaying images can be a very usefuldiagnostic tool. Light is emitted by a light source (for example, alight bulb, flash, ambient, or LED) and then reflected or absorbed bythe environment (for example, the atmosphere, skin, or mucous) prior tobeing captured, for example, using a film camera, CCD or CMOS chip.Lenses and similar components are considered herein as accessingelements. Light continues to be modified or transmitted until it hitsthe capturing/sensor element, for example, a CMOS or CCD chip. The lightmay be accessed, focused and transmitted prior to reaching the capturingelement by means of devices such as lenses, fibers, mirrors and filters.The captured image may differ depending on the light source. Forexample, in the morning and evening, the ambient light from the sun isdifferent and the scene viewed by an observer is different. Likewise,different LEDs or filters may be used to provide light of differentwavelengths. Wavelengths outside of the visible spectrum may also beemitted, filtered and or captured. For example, certain wavelengths maybe useful in distinguishing whether there is biofilm present, which isindicative of an infection, or be absorbed or reflected differently whenthere is fluid behind the ear drum. Variations of these features and/ormethods may be incorporated into a diagnostic device.

Light may be captured, by any light capturing device at any location onthe device, for example, near the end of the device, using a video chip(e.g. CMOS or CCD) or accessed at any location on the device, forexample, by means such as lenses, fibers and/or mirrors and channeled toa light capturing element. Devices containing light capturing elementsmay take many forms. For example, light may be channeled to a lightcapturing element in an existing device such as a smart phone, tablet orcomputer. Light capturing elements may also be incorporated intospecialty devices such as an earphone-type device or a specialtydiagnostic instrument which may have a form factor similar to that of asmart phone. Light may be captured/accessed directly in from the end ofthe device or capturing/accessing elements may be configured at an angleor to the side of the end of the device.

Multiple accessing and capturing elements may be incorporated into adevice. For example, two or more fiber bundles may be configured so thattheir ends are at different angles or locations. These fibers thenchannel the light to one or more light capturing elements (e.g. CCD orCMOS chip). This will allow different images to be seen. If the light ischanneled to a single capturing element, two different images may beseen in the same display. Software may be used to alternately displaythe desired portion of the image on the full screen. Alternatively, amirror may rotate to alternate the displayed images from the two or moredifferent fibers. If the fibers are positioned at left and rightpositions, the two images may be combined in order to create a 3-Dimage. If a single capturing element is used, software may be used todifferentiate the images and then create the 3-D image. Alternatively,straight channels and/or channels and mirrors may be used to transmitthe light to the light capturing element without the use of fibers.Alternatively, light capturing elements may be located the end of thedevice and capture the light at that location, at multiple locationsand/or multiple angles.

Light may be supplied in a variety of ways as well. Light may be emittedfrom a light source (e.g. LED) at the end of the device or light may betransmitted to the end of the device. For example, fibers, mirrors orstraight channels may be used to transmit the light to the desiredoutput location. Various filters may be used to change the emittedwavelength and/or more than one color or wavelength light source may beincorporated into a device. Filters may also be used just in front ofthe capturing element and/or software used to modify the exposure sothat certain wavelengths, brightnesses or other types of image variablesare modified or restricted from the image. Light may be output in avariety of geometrical manners as well. For instance, light may beoutput in a ring surrounding the video accessing and/or capturingelements, emitted from a single location adjacent to theaccessing/capturing element(s), or from more than one location relativeto the accessing/capturing elements.

Multiple accessing and capturing elements may be positioned to imagedifferent areas. For example, one may desire to see an image of theskin, throat or ear while also seeing a more contextual image, such ashow the device is being used and positioned. An example of oneconfiguration is using one of the cameras of a smartphone to capture animage of a child, and light is channeled using fibers from the child'sear to the second camera on the smart phone. Imaging accessing andcapturing elements may also be positioned to capture images in differentlocations of a desired target area, for example in the oral cavity andthen further away in the back of the throat. Imaging elements may alsobe located close to one another but facilitate capturing images atdifferent locations by having different focal lengths accomplishedthrough lenses or other components, for example using software that canfocus an image after capturing when used with a capturing element thatidentifies angles of the captured light, e.g., using Lytro cameratechnology.

Various methods may be used to maintain a clear image. For example, airor water may be channeled to the end of the device to maintain a cleanand clear end of the accessing element (such as a lens) or circulatedaround or behind the lens or other accessing or capturing element toprevent condensation or fogging. Anti-fogging fluid may also be appliedto the device prior to use.

An accessing element may also be expandable. For example, a tube may becompressed for accessing a location and then expanded (for example, byinflation) to expand the diameter or size and therefore access a greaterimaging area. Another example of an expandable device is one constructedof a central expandable member with accessing and/or capturing elementssurrounding this member. When the central member is expanded, thesurrounding elements are pushed out, accessing a larger area. Expandablemembers may also be used to change the position or angle of theaccessing/capturing elements. For example, an expandable member may pushthe accessing/capturing elements up into the top of the oral cavity orto one side of an ear canal. Similar techniques may also be used forlight sources.

Accessing and/or capturing elements may be configured for flexibility toallow conformance to a desired location (for example, an ear canal)and/or incorporate elements that allow the flexible elements to bemanipulated. For example, a fiber bundle may be steered by a user in afashion similar to endoscopes, or be remotely steered by a provider orother person. Alternatively, just the tip elements (such as a lens,mirror and/or light sensing chip) may be steered or manipulated.Manipulation of the elements may include modification of the focallength.

Other imaging techniques may also be incorporated into diagnosticdevices. One example includes ultrasonic imaging.

Sound can be detected using a diagnostic device using any number oftechniques. Sound may also be accessed and captured with a variety ofmethods. As opposed to light, sound may be captured through the airand/or captured after being transmitted through fluids or tissue ordevices. Microphones may be mounted on probes to record sounds when theprobe is in contact with the body or when placed into cavities such asthe mouth. These microphones may be placed at the tips of the probes oraway from the tips and record vibrations transmitted through the probes.Microphones may also be mounted on or in surface mounted devices.Examples of these devices include pads placed on, attached to, wrappedaround or worn on a body part such as a device similar to a knee braceor a belt or a vest. These devices may be designed to capture soundssuch as those emitted by joints, the heart and/or the lungs or airway.Microphones located at or close to the surface of the device near tissuemay capture more localized sound while microphones located deeper indevices and further from tissue may capture sounds from a larger area.Sound may also be accessed at a distance and channeled through a tube(s)to a microphone in a capturing unit.

Sound accessing elements may be “open”, or natural, or constructedsimilar to a diaphragm. This diaphragm may be designed to conform to thedesired area for a more thorough and reliable contact area and/or toamplify the sounds and/or to collect sound from a broader area. Thediaphragm may be similar to that of a stethoscope. It may attach to acapturing device with a microphone, such as a smart phone or a smallunit with a microphone that transmits the sound, preferably wirelessly,to a diagnostic processing device (i.e. a smart phone). Alternatively,the diaphragm and microphone may be incorporated into the same unitwhich attaches to a diagnostic processor which transmits the data,preferably wirelessly, to another diagnostic processing unit such as asmart phone which may output and/or store and/or send the data throughthe internet. This diaphragm, with or without microphone, may attach tothe same diagnostic processor as the light accessing element.

Sound may also be filtered and/or amplified. For example, when using adiaphragm and stethoscope type device, sounds relevant to the heartand/or lungs may be filtered and amplified while other sounds may befiltered and discarded. This filtering may be done by the diagnosticprocessing unit or at the provider end and may be controlled by theprovider. Also, microphones with different sensitivities may be used inorder to collect a larger range of frequency of sounds and/or largerrange of amplitudes. Once again, filters may then be used.

Movement can be detected or captured using any kind of motion-detectingdevice. Examples of such devices are strain gages and accelerometers.Pressure in tubes can also be used to detect expansion/contraction, andpressure or sound changes in bags/compartments can be used to detectmotion, for example, devices placed under a mattress. Such devices canalso be placed around a patient's legs, knees, or other body part fordetection of muscle or limb motion.

In certain embodiments, GPS units can be used to detect motion. Externalstereotactic devices, which devices track three or more points, can bemounted on various worn items; or wrapped on or affixed to a patient'slegs, vest, belt, or other part of the body or clothing.

Muscle spasms or tension can be monitored to detect or diagnoseconditions such as headaches which are often musculoskeletal.

Headband or bandage-type devices which contain strain gauges or othermechanisms can be used to detect motion and/or strain. Video cameras ormotion sensors such as the Kinect device can also be used.Microelectricalmechanical (MEMS) sensors and devices worn on the bodycontaining MEMS sensors (e.g., vest, belt, wraps, leggings, etc.) arealso useful.

Reflexes can be detected or captured, for example, by determining apatient's quickness in pushing buttons or other responses. The responsescan be tested in a gaming environment which can be hardware orsoftware-based. Devices can also have a mechanism for hitting nerves orother tissue to elicit a reflex response. The diagnostic instrument maybe integrated into a knee or elbow wrap or mount.

Patient health can be assessed using electrical-based diagnosticequipment to detect or diagnose conditions such as eye movement;hydration (resistance), and fat content (resistance), viaelectrooculography, electroretinograms, EEG, EKG, and/or EMG.

Temperature can be detected using various methodology, such as infrared,e.g. ear temperature or skin surface; or conductance; for example, usinga standard thermometer. Relative temperature can also be used betweendifferent body surfaces or regions.

Touch and pressure can be sensed using gloves with pressure sensors toindicate how hard a patient is pressing on something. Such sensors maygive a numerical or other scale feedback or provide a tactile outputthrough device on the provider end. For example, a glove with pressurecompartments may be modified to duplicate the pressures felt/recorded onthe user end. Socks with pressure sensors can be used for gait, or forpodiatrist assistance.

Other senses that can be measured include kinesthetics (relativeposition of body parts e.g., a patient is asked to touch his or her nosewith a finger with the eyes closed); or balance, magnetic/electricalfields, and pain.

The invention can also be used to measure or monitor standarddiagnostics or vitals. That is, the invention can be used to obtainstandard diagnostic information and vital signs such as pulse, oximetry,pulse oximetry, CO2 blood levels, cardiac output (arterial pulse), heartrate, glucose monitoring, blood pressure, and weight.

Other tests or diagnostics that can be used with the invention include,for example, swabs or blood pin-pricks. Third party diagnostic devicesand tests can also be incorporated through release of standardinterfaces or programming information.

Methods and types of diagnosis can be based on any combination ofdiagnostic information. There are numerous health ailments which may bediagnosed using any one of or a combination of the techniques discussedabove. Below is a short list of examples.

1. Imaging of the ear drum for ear infections. Such diagnostic tests mayalso take an infrared temperature reading;

2. Listening to sounds of four quadrants or lung on the back of apatient. Such tests may help to diagnose asthma or a respiratoryinfection;

3. Imaging of the skin to detect skin cancer, rashes, poison ivy, orother such ailments;

4. Images of the mouth and throat for upper respiratoryailments/infections;

5. Epiglottitis by listening to sounds near trachea; and

6. Diagnosing flu and common cold, using data such as body temperature,images of the throat and listening to lungs.

Anatomical Interfaces for Diagnostic Devices

Anatomical interfaces for diagnostic devices can have any shape orstructure. Examples of devices with anatomical interfaces includeotoscopes, rhinoscopes, and throat visualizers. While interfaces may bediscussed in reference to a specific diagnostic technique and/or device,such as an otoscope for imaging the ear, similar anatomic interfacesand/or devices may be used to collect any type of diagnosticinformation. An example is an anatomical interface for the ear similarused to collect temperature information rather than imaging information.Anatomical interfaces may include elements to collect more than one typeof diagnostic information. Examples of such devices will now bediscussed in further detail.

An otoscope may have features such as a flexible extension for easierinsertion into the ear and for alignment to the ear drum and to conformto the ear canal. This extension may have a feature to preventover-insertion or to limit the amount of force that is encountered. Forexample, the extension may be spring loaded and able to fully orpartially retract depending on the forces encountered. This retraction,or force limiting mechanism, may be incorporated into a more rigidextension as well.

There may be a soft outer material on the extension for comfort duringinsertion and while imaging. These may also be more rigid internalmaterial to maintain a desired shape. The extension may have a stop thatinterfaces with the patient to prevent over insertion into the earcanal. In one embodiment, the stop presses into outer ear and does notcompress tissue into ear canal. There may also be hole to allow air toescape during insertion and imaging, or to prevent echoing or otherbothersome noises.

The stop can be incorporated into a disposable sleeve, or it can have ashape similar to an earphone bud, or a cup around the ear. The diameterof the extension can also increase, thereby functioning as a stop in theear canal. There may also be adjustable stops or different-sized sleevesto fit different ages.

Ear buds that snugly fit in the ear such as the Doc's Ear Plug, may havean extension into the ear canal. Over ear devices similar to ear phonescan also serve as a stop or to provide alignment and/or to hold animaging device in place.

A small bud or a bud with an over ear holder can have one or more smallflexible wires connecting the bud to another device, or the bud may beself-contained and having RF, wifi, or other wireless communication linkwith a diagnostic computer and/or processor. Such devices allowsignificant motion and hands-free capturing of data, and suchembodiments help with freeing up a user to manipulate the ear. There mayalso be an LED at the tip or channeled from the outer ear into the tip.

Screw type or other adjustments can be used to change the length ofinsertion, and a balloon or other dilation method can be used to stopand hold the device in place.

Such devices fit into the ear and align the capturing and/or accessingelements. Ideally, the device will be able to image the ear drum withminimal or no manipulation of the ear. The capturing/accessing elementsmay be offset from the central axis of the ear canal and/or angledrelative to the axis.

The extension into the inner ear may be formed of a polymer or othermaterial. A lens can be in a central position, or it can be offset, andoptionally offset posteriorly. This extension may dilate the canal ifdesired.

There may also be different attachments for the left and right ears, andsuch attachments may connect to a capturing device and channel imagesfrom the tip. A tip which rotates to fit into and align elements withleft and right ear canal and ear drum is also possible and within thescope of the present invention.

Dilation of the ear canal is also possible by means of a balloon orother inflation device. This dilation may push imaging, light, or otherchannels outward for a larger viewing field and/or additional viewingangles.

Multiple attachments to fit different ear sizes or patient ages arepossible and encompassed by the present invention. Such pieces may bevery inexpensive and therefore disposable. There may also be moldableattachments for patient-specific fittings.

There may also be an extendable piece or longer extension fittings tosee deeper in the ear canal for better clarity and/or to get past earhairs. A head band, hat or similar retaining device can be used to helpsecure and hold the ear imaging device in place.

Many of the above features will also be useful in other anatomicalinterface embodiments.

For example, a rhinoscope may consist of a nose plug with various insertlengths and shapes, and a soft tip. There may be a soft outer materialsurrounding a more rigid inner material that maintains its shape. Theremay also be dual tips for both nostrils, which can be useful for imagingnasal cavities.

The invention also provides for an attachment to look into the throat.The attachment may consist of a narrower fiberscope when viewed from theside that more naturally conforms with the shape of the oral cavity,optionally with a mouth piece to depress the tongue and to open the oralcavity for better imaging. The mouth piece may be similar in shape to apacifier. The attachment may also have a slight downward curve todepress the tongue and to provide a downward angle further back in theoral cavity to image the throat. Similar to a pacifier, the outermaterial of this oral device would preferably be soft and/orsemi-compressible. The oral device may have any shape, and in oneembodiment is oval in shape, as pacifiers generally are, to morenaturally conform with the oral cavity. This oral device may begenerally flexible in nature and bend with motions in an oral cavityshould a patient, such as a child, resist to the device being used.

The invention also provides for a dermatoscope, which can maintain aspecific distance from the object to be imaged to enable measurementsover time. A dermatoscope may incorporate an object of known size forreference in images obtained.

The invention also provides for a heart rate (HR) type belt or similardevice which can be used to detect breathing sounds and to listen to thelungs as well as to check the heartbeat. Other devices to detect soundsare a vest with microphones, and a small interface similar in size tothe end of a stethoscope but attachable to a smart phone or other devicewith a microphone or containing a microphone and interfacing with anadapter to send the sounds to a computer.

Certain embodiments of the invention provide for a method to detectinternal sound by external diagnostic equipment. One purpose is to helpgive a sense of what the patient feels, and such embodiments areparticularly useful for orthopedics.

An example of a device having these features is a brace for the back,knee or other area to pick up sounds (ideally internal) that may aloneprovide a diagnosis or provide reassurance when combined with otherdiagnostic data such as images.

The invention also provides for a small probe inserted through thetopmost layer(s) of the skin.

The invention also provides for a probe which may be inserted into abody cavity (e.g., oral, stomach, intestines, etc.). Examination of theoral cavity may help with GERD diagnosis. The obtained data can be usedto correlate sounds with specific ailments or to narrow downpossibilities or identify potential issues.

The invention also provides for a device for measuring temperature,which may consist of an IR detector built into an ear bud or similardevice. The ear device may be held in place with a hat or head band.Alternatively, the temperature detector can be built into a head band orhat device with skin contact probes, and be optionally positioned on apatient's forehead area.

The invention also provides for a device for measuring oxygensaturation, for example, in the form of a finger or toe attachment.

The invention also provides for a device for measuring blood pressure,for example, for placement on a patient's wrist or arm.

The invention also provides for a device in the form of an eye piece(e.g. a cup-type shape) to provide safe imaging of eye and surroundingtissue.

Particular embodiments of capturing devices have a thin sleeve and/orcovering that is disposable and which maintains a barrier as well asproviding padding for comfort during a medical examination. There mayalso be stops to prevent over insertion (e.g., for an otoscope).Adhesive patches for skin mounted or contact devices can be used. Thecapturing device may also have a moldable interface.

The capturing device may also be integrated with a device to view, hearor otherwise observe or sense the diagnostic information. This may be adiagnostic processing unit as discussed later, or a simpler typeinterface such as an optical viewport to see the images through thediagnostic device. This device may or may not include componentsallowing storage or transfer of the diagnostic information. Suchcomponents may include software, mechanical elements, and/or other humaninterface to manipulate output.

Diagnostic Processing and Link to Diagnostic Device

The diagnostic processing components (sometimes referred to asdiagnostic processors, or processors or processing components) allow forreceiving, transmitting, outputting and/or recording diagnosticinformation and/or uploading the information to the internet. Theinformation may be stored at a remote location if the information isbeing uploaded.

The diagnostic processing components may communicate with the diagnosticaccessing and capturing components through a wired or wirelessconnection. Examples of wireless communication include RF (e.g.Bluetooth), wife and/or wireless phone technology. An example of such aconfiguration includes a small wireless transmitter which attaches toand is wired to an image capturing device and transmits (preferablywirelessly) the data to a smart phone, tablet or other computer. Thiscomputer may then display the images, record the information and/orupload the information to the internet.

All processing components may be integrated into a single device, forexample, a tablet, smart phone or other computer. An image accessingdevice with an anatomical interface is then positioned in front of thecomputer camera. The computer is then able to capture, record, displayand/or upload the information. This computer may also serve as thecommunication device.

The accessing and/or capturing components may also be mechanicallyattached to the processing components. An example of this is a cradlewith handle and a device with an anatomical interface housing a lens,video chip and RF transmitter, as well as other electronics. The cradleholds a tablet, smart phone or other computing device. The images arethen sent (preferably wirelessly) from the device to the computingdevice in the cradle for displaying, recording and/or uploading. Inanother embodiment, a folder, portfolio, or carry case may hold acomputer tablet on one side for communication and a smart phone ortablet on the other side to receive, record, display and/or upload thediagnostic information.

Diagnostic Processing Components

Part or all of the diagnostic processor may be the same as thecommunication device (e.g. laptop, tablet, smart phone) or otherexisting computer device (e.g. desktop, second communication device).

The diagnostic processor engages in wired or wireless communication to adiagnostic capturing device. The diagnostic processor may also serve asthe diagnostic capturing device, for example, having an anatomicalinterface which attaches in front of a smartphone camera.

The diagnostic processing components may be built into the diagnosticcapturing device. For example, a wireless transmitter may be attachedand wired to a capturing device. The diagnostic information is uploadeddirectly to the internet and then may be downloaded to a communicationdevice.

Alternatively, the diagnostic processing components may be located inanother device, such as a base station. The base station can be locatedanywhere in the home or other facility, and is typically plugged in apower outlet and connected to the internet or a wireless service. Thisstation communicates with and receives the information from thediagnostic capturing device. Information may then be transferred to acommunication device and/or directly uploaded to the internet. Ifdirectly uploaded to the Internet, the information may then bedownloaded for display or other output in the communication device.

The diagnostic processing unit can also be a local “box” thatcommunicates/connects to the diagnostic capturing device. The diagnosticcapturing device may transmit the information wirelessly (e.g. RF) tothe local box or be connected with a wire.

The local box may optionally be configured to display diagnosticinformation. This box may attach directly to the diagnostic capturingdevice, be hand held and allow moving and placing the diagnosticcapturing device as desired

Other form forms include a watch or a flexible display that may beunfolded if applicable and placed in a convenient location. The localbox or similar device is usually situated to be mechanically and/orelectronically attached or linked to a communication device aspreviously discussed.

The device can also serve as a communication device, particularly if ithas a display screen.

The local box may transmit information to a smart phone, tablet or othercomputer for outputting, recording and/or uploading the information.

Multiple devices and communication methods may be combined. For example,the diagnostic capturing device may have diagnostic processingcomponents built in to record the information and/or display theinformation and also transfer the information to a local computer orcommunication device as well as directly transmit the information viathe internet or wireless phone technology.

The local box or electronics may allow attachment to a multitude ofdiagnostic devices and be able to transmit the data to the internet, thecommunication device or other device as previously described.

The diagnostic processing components may also have a mechanical link forinformation transfer. The diagnostic accessing device may have a hollowtube for transmission of sound or fiber optics for transmission ofimages to a diagnostic processing device. The diagnostic processingdevice may have the hardware required to capture and process theinformation. Examples of hardware include a camera and/or microphone,and may include a cradle or other attachment to help align parts foradequate capturing of the diagnostic information.

The diagnostic processing component(s) may be able tocommunicate/connect to third party diagnostic devices as well. Forexample, a local box as previously described may communicate with heartrate monitors, pulse oximeter, scales, blood glucose monitors, etc.

Other features of a diagnostic processor and/or capturing device mayinclude a conventional camera, a microphone, and/or a recorder. Theseelements may include a mechanical and/or electronic link between theanatomical interface and the camera or microphone to provide fortransfer of the diagnostic information.

Examples of Diagnostic Devices and Additional Features

Different devices which are created by combinations of disclosedfeatures and components discussed in above sections can allow foraccessing and capturing of data, an anatomical interface, and diagnosticprocessing.

A diagnostic device may have channels for secondary uses. For example,an otoscope for visualizing the ear drum may have a channel to allow airto be inserted into and pressurize the ear canal to visualize motion ofthe ear drum. Alternatively, additional diagnostic techniques which arenot discussed herein may be incorporated into any diagnostic device.

A diagnostic device may have multiple diagnostic capturing elements. Thediagnostic device may be held in place on the patient's body using anygenerally available or suitable means. For example, an otoscope may havean image capturing device and a temperature probe (such as an infraredthermometer). This ear device may be held in place with a head band, hator similar retaining device. The temperature reading apparatus may alsobe positioned in the hat or head band rather than in the ear piece, andhave skin contact probes which are ideally positioned near or on theforehead. Temperature readings may be recorded both within the ear andon the forehead to increase the likelihood of recording an accuratetemperature.

Kits containing more than one type of diagnostic device and/oranatomical interface are provided by and encompassed by the presentinvention.

Diagnostic devices may have features to make them more comfortableand/or acceptable to the patient. Such features may include, but are notlimited to a speaker in an ear piece (e.g. otoscope) playing soothingsounds or music that the patient finds enjoyable or vibration in a skininterface device (e.g. dermatoscope). An oral device or device to lookinto the throat (e.g. laryngoscope) may include a video screen situatedin front of the patient to play videos for the patient and/or include apleasant tasting mouth insert or the ability to apply a pleasant tasteto the oral device or laryngoscope.

As illustrated and described herein, many devices are formed to befamiliar to the user and therefore make them more comfortable andpleasant to use. For example, an ear imaging device with an earbud orover ear engagement member are similar in feel and use to headphones.The user may feel comfortable using such device and requires little orno instructions on using it. Similarly, an oral device for capturingdiagnostic information, such as images, may be shaped in an oval form.This oval shape will more naturally conform to the mouth. The oval shapemay resemble a pacifier or have another known shape. Users may feel morecomfortable and safe using a device on themselves or their child sincethe device resembles a product they have used before. Further, devicesare preferably constructed to resemble consumer products rather thanmedical devices to provide a more pleasant experience and also decreasethe time and effort to learn how to use the device.

F. Remote Control and/or Manipulation of Diagnostic Device and/orDiagnostic Information

The invention can provide live feeds with the ability to request asnapshot or segment in higher resolution. The invention also permits lowresolution viewing of large files such as MRIs, and the ability torequest high quality images of select images or parts of images.

In certain embodiments, the invention can pull information fromelectronic health records and/or a central location of storedinformation. Such data files can be reviewed in low resolution and thenselected files or portions of files can be retrieved for high resolutiondownload.

The invention also provides the ability to modify device settings, suchas filtering of sounds, zooming cameras, selecting which angle view isbest, changing filters of images, increasing/decreasing electricalpower, changing light source, selecting a camera, or modification of anyother option previously discussed. There is also the ability of remotemonitoring and/or control of a user device.

There may also be controlled articulation of a device, to change anangle or other shape to help navigate or align an instrument, or tochange a tip angle or angle of elements such as a mirror or video chip.

IV. Accounts, Logistics and Infrastructure

Examples of User and Provider Account(s)

Several kinds of user accounts and provider accounts are possible inaccordance with the principles of the present invention. There may be ananonymous account, in which billing and personal information isprocessed by a company or service, or a third-party service ortelehealth service, or by the company described within), but theprovider does not know the patient's identity and health records are notupdated. This option allows advice only, and no prescriptions.

There may also be a basic account with consumer identification. Basichealth information/background is collected during call, similar to avisit to a pharmacy clinic.

There may also be a basic account with past medical history completedfor use with this system. Certain information, for example, a simplehealth questionnaire, remains separate from other patient records.

There may also be an account which provides for integration with thepatient's existing Electronic Health Records (EHRs). Such accounts maypull out a subset of basic health information only for purposes of usein conjunction with the current sick call to keep the majority of theinformation private. The patient or caregiver decides what kind ofinformation or which categories of health information is shared. Thissharing could be done for each sick call.

Shared information may optionally be linked to a third party EHR. An EHRcan be managed within this system. Health information can also be sentas required to update the patient's record(s) and pulled from otherrecords as necessary.

Accounts can be created by the user, the user's health insurance,employer, family member, or another interested party.

An account can be created with health insurance information, or theaccount can be completely private and provide for separate billing via aself-pay model.

Patient accounts will be determined in accordance with particularimplementations of the invention. Such accounts are envisioned to befully HIPPA compliant, and the consumer controls and chooses whatinformation is shared and with whom. Permission from the patient may betransmitted with any medical data and/or via a separate/independenttransmission method or file.

Provider account(s) may include call records maintained (e.g. usersatisfaction), and provider credentials.

Completion of Communication

Both parties may first need to agree that an acceptable resolution hasbeen reached prior to completing the call as well as agree to whichinformation may be stored prior to the uploading and sharing ofinformation to an EHR or updating of any other record.

Billing and Insurance

The invention is amenable to different kinds of billing and insurancemodes. For example, there may be a self-pay mode, or the user orprovider can bill an insurance company and generate the relevant forms.

Communication Security and Methods of Transferring Information

The invention can use existing technology/company/software such asVidyo, or such technology can be created from the ground up in-house.

E. Recording of Information

The invention can provide for multiple record storage options. Forexample, the invention can record entire communications and allimaging/collection of diagnostic information, or the invention canrecord only short segments or snapshots of diagnostic informationselected by the provider and the final diagnosis and/or advice given.Alternatively, the invention can store only a form containing healthhistory and a written diagnosis by the provider, with or without images.Prior to providing or receiving any service, the patient/consumer andhealth care provider can agree on completed review and storage ofinformation.

F. Database Management

Database management for a particular implementation of the inventionwill generally be conducted in accordance with industry practices andregulations.

G. Interfacing with 3rd Party Software and Hardware Including ElectronicMedical Records (EMRs) and Diagnostic Devices

The invention can also interfacing with third party software andhardware providers, including those providing or storing ElectronicMedical Records (EMRs) and diagnostic devices

V. Telehealth Systems and Features

Telehealth systems in accordance with the present invention permit thelinking of two or more parties at remote locations to aid with ormonitor medical conditions. The connections may be in the form of avoice call, video call and/or text communication or any of these withthe addition of sharing information such as photos, files and/ordiagnostic information, collected previously and/or collected duringcommunication.

Communication methods may include cellular/mobile telephone, through theinternet, via satellite, landline or any other technology enablingcommunication protocol.

Telehealth systems utilize diagnostic or health information collectedwith a variety of methods or available from previous healthconsultations. A third party device or a diagnostic device describedherein, or other information such as xrays, MRIs, blood tests orinformation contained in an electronic health record can be utilized.

Telehealth system in accordance with the invention may involve anofficial diagnosis, e-prescriptions, billing (individual and/orinsurance), creation of insurance forms and/or updating EHRs.

Such systems also use software and/or user interfaces to facilitatecapture, output (e.g. display or sound), transfer and/or recording ofinformation.

Infrastructure, including servers and databases, can be purchasedcommercially or custom-designed, depending on the implementation of theinvention.

Health care providers such as physicians or other professionals may beranked by education, experience, user satisfaction or other means bywhich a user may wish to select a provider. Users or insurance companiesmay pay different amounts depending on the rank of the provider, orbased upon prior negotiation.

Certain embodiments of the invention may be desirable for use in agaming, social, or educational setting. For example, the invention canprovide a 3D tour through the body and participants would guess medicalsolutions or diagnoses based on real data or examples for eachlocation/area of the body. Users may get points and compete againstothers.

There may also be crowd-sourcing to other users for opinions withoutprovider input. Users may compete against each other and be ranked forknowledge which may help in the probability of obtaining correct advicefrom the crowd.

The invention can also use real data for educational purposes with aninteractive interface, e.g., a 3D tour through the body. The inventioncan also include demonstrations and illustrations of how a healthailment may have been caused and how to prevent or treat that condition.

Certain embodiments of the invention can be used for auto detection ofailments, for example, ear infections and progression of moles, and theinvention can give the probability that the patient has the illness withor without an additional provider consultation. Software and analysiscan be done on the user device and/or as a “cloud” service.

There may also be crowd sourcing for two or more opinions fromproviders. Such embodiments may be particularly applicable to lowerincome countries or those having lower provider cost (such as India) andfor easily-diagnosed ailments requiring only an image or similarlysimple sharing of diagnostic information. This would give a potentialfor extremely short provider review times, potentially in just 10seconds.

The invention can also be used to solicit bids from providers forconsultations, surgery or other care. A user may also offer a set amountfor diagnosis and treatment, and providers may choose to accept theuser's offer or not.

The invention can also be integrated with outside diagnosticsfacilities, for example, for lab tests or culture testing; to enableusers to send samples such as blood, mucous, and skin shavings foranalysis; and to schedule appointments for blood draws/testing orimaging tests such as x-ray or MRI.

Contacts between patients/caregivers and medical care providers can bein any form, such as the following:

1. Direct peer to peer or through central server/gate or simultaneouslypeer to peer and to central location;

2. Caregiver and patient;

3. Patient and provider (or nurse/call center for routing if necessary);

4. Patient, caregiver to provider(s);

5. Caregiver to provider and separately to patient;

6. Patient separately to caregiver and provider; and

7. Any of the above with a facilitator such as a nurse or other trainedindividual at a call center;

A non-limiting list of examples of sick calls or requests for medicalservices can include requests for second opinions; treatment of acuteailments; treatment of chronic ailments; requests for follow-upappointments; scheduling physical therapy; monitoring, which can beinitiated by caregiver and not require an active answer by the patient;fitness or wellness visits; and emergency and other urgent medicalcalls.

The invention can be provided to consumers in numerous ways, such as byhealth insurance companies, employers, through partnerships with healthIT companies, or directly to consumers.

Different kinds of systems are possible within the scope of the presentinvention. For example, there may be a basic system, which providestelemedicine with at least voice capability and optionally videocapability to enable remote diagnosis and prescriptions as necessary.There may also be diagnostic device services, in which the inventionprovides the ability to capture and send medical data and informationfrom a patient to a health care provider. The systems may also have theability to transfer a live feed of diagnostic information from thepatient to the provider, or the ability for the provider to selectsnapshots or short segment video to download in high resolution from thediagnostic device.

There may also be a hardware or software interface to allow connectionof any diagnostic device, e.g. for example, from a third party. Theseconnections can be live feeds or collected over time such as bloodglucose or heart rate and input by user, for example, by typing bloodpressure readings into a diagnostic device. For live feeds, in oneembodiment, the invention allows for recordal of information and data,and for remote transfer of high quality images.

VI. Systems with Therapeutic Elements

The invention may also be in communications with medical devices whichprovide remote therapeutic elements or services to a patient. Examplesof such devices are massage devices or muscle or nerve stimulationdevices. The medical provider can send remote instructions to thesedevices so that the patient can obtain therapeutic treatment.

As described herein, various embodiments of the disclosed systems andmethods significantly improve efficiency for patients, clinicians,health system managers, and third party payers. The stored patientinformation allows reviewing clinicians to see the patient examinationand glean valuable information that a previous clinician might havemissed during a routine examination. Moreover, multiple cliniciansand/or specialists can access the patient information simultaneouslyand/or sequentially, allowing additional reviews to review the data andreduce the chance of something being missed or overlooked.

The system can include features that allow consultants to review thecomments and recommendations of other clinicians. In doing so,consultants may be exposed to the thoughts of other clinicians, which inturn can broaden or focus the clinical impressions more accurately, andagain reduce the chances of error or misdiagnosis. Such review willnormally be done within the data sharing permissions set by the patient,as well as within the scope of medical record sharing laws andregulations.

Various features of the disclosed system may encourage patientparticipation and involvement. The patient has opportunity to see his orher case, actively monitor the progression and assessment of theinformation by medical professionals, and review the various commentsand recommendations and actively participate in his/her case. This mayresult in a more informed and involved patient, and can significantlyincrease patient satisfaction with the medical care and response.

In various embodiments, the user's initial patient information andtreatment request creates a query that becomes available to the medicalprofessionals (e.g., consulting clinicians) via a secure web portal orother format. The system provides the medical professional with therelevant patient data to be used in providing recommendations regardingthe patient condition, assessment and/or treatment. The medicalprofessional can review the query on-line at any time after it has beenposted and can record his/her observations and recommendations into thequery file as necessary and/or desired. Depending upon the patientcondition and/or complexity, an initial assessment can be rapidlycompleted, for example, in 15 minutes or less, by properly trainedpersonnel such as nurses, initial assessment technicians, or firstresponders. Such initial assessment may take significantly less timethan needed for a clinician to evaluate the patient in person. Forpatients requiring further in-depth assessment and/or analysis, theirqueries may be forwarded to a relevant specialist, while less complexqueries can be addressed and responded to by a wide variety ofless-expensive clinical specialists. This can significantly reduce thecosts incurred to evaluate the patient, which may result insignificantly lower costs for the patient and/or payor. In addition, thepatient does not need to directly meet with clinicians individually,which may significantly increase the convenience and accessibility ofhealthcare.

Various features of the disclosed systems and methods may furtherfacilitate the collection and recordation of patient demographics,medical histories, complaints, illness histories, height, weight,identification (e.g., fingerprints, facial photographs, DNA or bloodtype information), patient statements, video exam sequences, andphysical characteristics such as physical inspection results, thermalimaging, palpation, strength, sensation and reflexes. In addition,various information relevant to the complaint can include links toelectronic medical records, links to imaging databases, various clinicalcomments, and billing information. Patients can give permission for theattending clinician to access their stored health records. The cliniciancan provide the most rapid physical examination if a patient's recordsare all available electronically. Nevertheless, the invention can alsobe highly effective to start developing a patient's electronic healthrecord.

Use of the various systems and methods disclosed herein may be ofinterest to health systems administrators as it may facilitate ahospital or clinician group's expansion of their service area, attractpatients to their treatment facilities, promote utilization ofparticipating providers, create multiple revenue streams, and may be apowerful marketing tool. In various embodiments, the systems addefficiency and increase clinical productivity.

In various embodiments, researchers may utilize various databaseinformation which may include data mining features, standardization ofexamination methods, and an objective documentation format. Similarly,health care professionals and/or educators may utilize various featuresthat provide a rich educational format that can be accessed by studentsseeking to gain knowledge regarding the evaluation and management ofhealth issues. The patient information files may be archived and used toprovide exposure to a wide variety of cases and demonstrate variouspathologies to students who might otherwise go years before seeing anexample of certain variant conditions. In various embodiments, amultidisciplinary consultation feature can be provided that allowsexposure of patient information to a variety of medical perspectives.Such data sharing will normally be used in accordance with local privacylaws.

Various features of disclosed embodiments offer significant direct costsavings, which may be realized when an emergency room or full officevisit consultation is avoided because the information is available viathe system. The system saves time because the patient does not have towait to attend a variety of appointments and each clinician (if multiplemedical professionals are required or desired) can view the patientinformation remotely on his or her own time. In addition, multipleconsultations and opinions can be collected via the systemsimultaneously.

Advantageously, the system can increase quality by making multipleopinions available to the patient, which can increase patientresponsibility and autonomy and facilitate greater levels of involvementin patients' own health care. In various embodiments, patients may begiven the option of selecting a desired clinician or clinical specialtythat they would like to consult on their patient information. Thepatient can directly review the various opinions and recommendationscollected in the system and make their own choices about how they wouldlike to proceed. Patients can increase their understanding and knowledgeof their condition by allowing them (or anyone else they so choose) toview their personal examination compilation in detail. In addition, thesystem allows third party payers to have a more complete and accurateassessment of the claimant's examination compilation.

The present invention will now be described with reference to theFigures.

FIGS. 1 and 2 illustrate exemplary embodiments of a telehealth system inuse in accordance with an aspect of the present invention. FIG. 1illustrates a caregiver and a health care provider engaged in a videocall, thereby interacting in two-way video and voice communications. Adiagnostic device in accordance with the present invention has beeninserted in to the patient's ear, and the diagnostic device acquiresmedical status data, including diagnostic images, and provides thisinformation to the provider. During the video call, the provider canrequest that the caregiver or patient provide additional medicalinformation or adjust the settings or placement of the diagnosticdevice. Although the figure shows the caregiver using a laptop computerand the provider using a desktop computer, the caregiver and providercan use other kinds of computer systems, such as the illustratedsmartphone or tablet computer. In certain embodiments of the invention,caregivers and/or providers will install an application or an app ontheir devices to communicate. In view of current U.S. federal privacylaws, it is expected that all communications between a provider andpatient/caregiver will be done over a secure electronic connection.

FIG. 2 illustrates an exemplary embodiment of the invention whichprovides for a plurality of data feed options to the provider from thediagnostic device. In the illustrated embodiment, the provider canchoose to receive one or more high-resolution images via download, orthe provider can receive a low-resolution live feed. The provider hasthe ability to manipulate the diagnostic information and/or the deviceby a remote control feature. In this specific Figure, the diagnosticdata can be fed live to the provider at low resolution for seamlesstransfer and communication. The provider may select segments orsnapshots of the diagnostic feed which will be downloaded to him or herat a higher resolution. The full stream of higher resolution data can bestored on the user's device and/or at a central location, and accessedby the provider for high resolution snapshots/segments or for laterreview. The provider may use the remote control feature for otheractions, such as but not limited to focusing the image, controlling tipdeflection or the direction of an imaging device, and filtering sounds.

FIG. 3 illustrates linked components of an exemplary embodiment of atelehealth system according to the present invention. The system iscomprised of three components: (a) a user subsystem configured forreceiving a patient's current medical data; (b) a provider subsystemconfigured for communicating with a health care provider; and (c) aninfrastructure subsystem configured to process and store medical dataand diagnostic information received from the user subsystem and theprovider subsystem.

In the illustrated embodiment, the user subsystem comprises acommunication device; a diagnostic processing device; and a diagnosticcapture device. The provider subsystem comprises a communication device.The infrastructure subsystem comprises: (a) an application servercomprising computer instruction code configured for communication with(i) a database configured to store a patient's personal information andelectronic health record as well as information on providers; (ii)diagnostic computer instruction code configured to receive currentpatient medical information and to provide diagnostic informationconcerning the patient's medical condition; and (iii) a databaseconfigured to store archived diagnostic information; (b) a servercomprising computer instruction code configured to communicate with oneor more third-party patient personal information or electronic healthrecord databases; and (c) a server comprising computer instruction codeconfigured to communicate with a third party telehealth system.

FIG. 4 illustrates three components of a user subsystem of a telehealthsystem in accordance with an exemplary embodiment of the invention. Theuser subsystem comprises a communication device, which can be capable ofparticipating in a video conference. For example, the communicationdevice can be a laptop, tablet, or smartphone equipped with a videocamera.

The user subsystem also comprises a module which processed diagnosticinformation. This system transmits information, receives diagnosticinformation, outputs or displays information, records any diagnosticdata, and transfers this information to the Internet, for example, to astorage unit which may be cloud-based or stored or warehoused on aproprietary site and/or to the communication device.

The user subsystem also comprises a module which accesses and capturesdiagnostic information. This module can comprise an anatomicalinterface, such as an earbud, and can focus and access diagnosticinformation via a diaphragm, lens, fiberoptics, or other element. Thismodule can also capture diagnostic information via speakers or a camera.

FIGS. 5-7 illustrate exemplary embodiments of user devices structurallyconfigured for insertion into the human ear which communicate apatient's current medical status in accordance with the presentinvention. The user devices can include various kinds of communicationsdevices, which may not have any diagnostic capabilities (as shown inFIG. 5), or which can have a diagnostic processor (as shown in FIG. 6),or which can have a partial diagnostic processor (as shown in FIG. 7).In these Figures, an ear bud having a camera is used to access andcapture diagnostic information, and the ear bud communicates directlywith a smartphone (FIGS. 5 and 6), or indirectly through a smallintermediate box which has a partial diagnostic processor for receiptand transfer of information (FIG. 7). The earbud transmits photos of theinside of the ear canal wirelessly via BlueTooth (BT) or radio frequency(RF), although in certain embodiments this information can betransmitted via a wire connected to the jack or port of the tablet,smartphone, or other device.

FIGS. 8 and 9 show a cross-section of the ear region of a patient's headfor purposes of reference.

FIGS. 10-20 illustrate exemplary embodiments of an ear imaging devicecomprising an anatomical interface to facilitate positioning and imagequality and may also serve as safety mechanisms that prevent overinsertion. As discussed earlier, diagnostic devices may contain anycombination of elements described. For example, in FIGS. 10-20, outerear elements may contain LEDs in the outer ear elements which emit lightwhich is transmitted by standard components such as fibers, channels orlight pipes.

FIG. 10 shows an ear bud which is used to position and align, in theposterior of the ear canal, an imaging apparatus with the ear drum tooptimize the quality of the resultant images. The ear bud and imagingapparatus are attached to a port on the smartphone which aligns with thecamera for image capturing.

FIG. 11 illustrates an ear bud attached to an outer ear element. The earbud contains the imaging apparatus with a video chip at its tip. Theouter ear element contains the necessary electronics and transfers theimage, via radio frequency, BlueTooth, wire, or other protocol, toanother device such as a smartphone for output and display of themedical data to the Internet.

FIG. 12 illustrates an ear bud and outer ear element. In this Figure,the outer ear element contains the video chip as well as any ancillaryelectronics. The ear bud has fiber optics or a channel to allowtransmission of the image to the video chip. The entire embodimentconsists of a single hardware element.

FIG. 13 illustrates another combination of an ear bud and a detachableouter ear element. In contrast to FIG. 12 which shows a single hardwareelement, FIG. 13 illustrates that the components are detachable. Thisembodiment allow for different sizes of ear buds to be supplied, as wellas permitting different buds for left and right ears when necessary.

FIG. 14 shows an embodiment of the inventive device in the form of astandard speculum. This embodiment is configured with extra material onthe anterior (front) side in order to position the speculum to a moreposterior (backward) position for better alignment with the ear drum.

FIG. 15 illustrates an embodiment of the inventive device in the form ofa speculum, with an anterior buildup and extension attached to asmartphone for image capture. The speculum element may alternatively beattached to a different diagnostic processing device (such as the outerear element shown in the earlier Figures) to capture the image.

FIGS. 16-18 show alternative examples of ear buds and imaging apparatus.FIG. 18 shows a compressible ear bud with an imaging apparatus forconformity and secure fitting with an individual's ear. FIGS. 19 and 20show examples of an ear bud and imaging apparatus that repositionsitself as the ear is manipulated.

FIG. 21 illustrates features of the outer human ear for purposes ofreference.

FIGS. 22-24 illustrate exemplary embodiments of an over-ear device forobtaining a patient's current medical status. FIG. 22 shows an over eardevice, comprised of an outer ear element on the helix, and an ear budinside the ear canal. FIG. 23 shows the embodiment of FIG. 22 separatelyfrom the ear for clarity of view. FIG. 24 shows an embodiment of an overear device to which a video chip, a light source, and a speaker havebeen affixed.

FIGS. 25-26A-D illustrate exemplary embodiments of an over-ear deviceand different configurations of the outer ear elements. FIG. 25 shows abottom view of an over ear device. A video chip is illustrated withinthe outer ear element (the over ear piece). FIGS. 26A-D show a pluralityof different configurations of outer ear elements, ear buds, and videochips. An outer ear element may be configured with one or more videochips to allow for left and right ear buds to be attached. More than oneimage may also be captured, for example, at different locations of theear, or at different angles.

FIGS. 27 and 28A-F illustrate side and bottom views of an exemplary earimaging device. FIG. 27 shows a side view of an ear imaging device. Thedevice may be configured for interface with the patient's anatomy sothat the images are captured centrally or off-center, as shown in thelower two illustrations. FIGS. 28A-F show bottom views of an ear imagingdevice. The device may be configured and interfaced with the patient'sanatomy so that images are captured centrally, off-center, and/or at anangle, as illustrated in the five drawings at the bottom of the Figure.

FIGS. 29 and 30 illustrate exemplary embodiments of anatomicalinterfaces for a medical device for insertion into a patient's mouth(FIG. 29) or ear (FIG. 30). The anatomical interfaces are attached to asmartphone in the illustrated embodiment. The attachment of theanatomical interface to the device may be rigid (FIG. 29), or flexibleas shown in FIG. 30 with a spring/coil combination.

FIG. 31 illustrates an exemplary embodiment of a medical diagnosticinstrument equipped with a microphone. In the first image, a diaphragm,anatomical interface, and accessing device are shown attached to asmartphone with a microphone for capturing sound. In the second image, adiaphragm, anatomical interface, and accessing device are attached to aspecialty diagnostic capturing unit with a microphone which transmitssounds via a wired or wireless connection. Such an embodiment can beused to listen to heart or lung sounds, and the device can be used toperform the functions of a standard stethoscope.

FIGS. 32-35 illustrate exemplary embodiments of medical diagnosticinstruments for collection of patient medical information. FIG. 32 showsa strap with microphones. This embodiment can be used, for example, tolisten to a patient's chest or lungs when applied to a patient's chest.Similarly, FIG. 33 shows a shirt or vest which contains microphones.When the patient dons such articles as the strap or shirt/vest, thehealth care provider can listen remotely to sounds from the patient'sbody and thereby provide a diagnosis of a medical condition.

FIG. 34 illustrates an oral device, in the general form of a pacifier,which contains a lens and video chip for use in examining a patient'smouth or oral cavity. The oral device is equipped with digital imagingelements which communicate with a diagnostic processor to enable remotediagnoses. Such embodiments are useful to any patient, although theywill provide particular application to small children.

FIG. 35 shows an embodiment of a medical device comprising an oraldevice and an ear bud. The oral device and the ear buds both have fiberoptics or channel to interface with a device having a video chip and theassociated ancillary electronics, and these elements communicate with adiagnostic processor to provide medical data of at least two separateparts of patient's body.

FIGS. 36-37 illustrate exemplary embodiments of kits comprising devicesfor accessing, capturing, and at least partial processing of medicaldiagnostic information in accordance with the present invention. FIG. 36shows a kit comprising a strap equipped with microphones, an oraldevice, nose attachments, and different sized ear buds. These elementsall communicate with a processing box which interfaces with acommunication device for transmission of data to the medical provider.Any combination of these elements can be used in accordance with thepresent invention to transmit patient medical data to a provider. FIG.37 shows a kit comprising a computing device, such as a smartphone,tablet, or laptop, to provide communication and partial processing ofdiagnostic information. The kit also comprises devices for accessing andcapturing diagnostic information and at least partial processing of themedical data, including transferring the information to a communicationdevice such as the smartphone, tablet, or laptop just described.

FIGS. 38A-38E illustrate exemplary embodiments of medical diagnosticdevices in accordance with the present invention which are structurallyconfigured to be placed on, in, or adjacent to a patient's body forobtaining medical diagnostic information. These devices can contain abattery in an inner compartment for powering the device or fortransmission of obtained medical data.

FIGS. 38A-38B illustrate exemplary embodiments of medical diagnosticdevices having an anatomical interface, and which are structurallyconfigured to be placed into a patient's ear canal. The illustrateddevices are rotatable about certain positions to permit optimal fittinginto the ear canal.

FIGS. 38C-38D illustrate exemplary embodiments of medical diagnosticdevices which are structurally configured to be placed in a patient'soral cavity. The devices have a main body which can be inserted into thepatient's oral cavity to permit optimal data collection. These medicaldiagnostic devices have an anatomical interface component whichinterfaces with the user's hand.

FIG. 38E illustrates an exemplary embodiment of a medical diagnosticdevice which has stethoscope capabilities, and which is structurallyconfigured for listening to sounds from a patient's body. The device hasan anatomical interface component which can be applied to a patient'schest, back, joint, or other location for listening to sounds.

The various embodiments described above can be combined to providefurther embodiments. Aspects of the embodiments can be modified, ifnecessary to employ concepts of the various patents, application andpublications to provide yet further embodiments.

Other objects, advantages and embodiments of the various aspects of thepresent invention will be apparent to those who are skilled in the fieldof the invention and are within the scope of the description and theaccompanying figure. For example, but without limitation, structural orfunctional elements might be rearranged, or method steps reordered,consistent with the present invention. Similarly, a device may comprisea single instance of a device or comprise a plurality of devices, suchplurality functioning as a single device working in tandem. For example,a computing device may consist of a plurality of computing devices whichtogether provide the desired functionality. The device types describedin various embodiments are not meant to limit the possible types ofdevices that may be used in embodiments of aspects of the presentinvention, and other types of devices that may accomplish similar tasksmay be implemented as well. Similarly, principles according to thepresent invention, and methods and systems that embody them, could beapplied to other examples, which, even if not specifically describedhere in detail, would nevertheless be within the scope of the presentinvention.

The following listing identifies elements illustrated in the Figures andprovides the respective figure reference numeral for each of theidentified elements.

REFERENCE NUMERAL ELEMENT

-   -   10 Telehealth system    -   12 Provider    -   14 Caregiver    -   16 Patient    -   18 Diagnostic device    -   20 Communication component    -   22 Processing component    -   24 Accessing element    -   26 Capturing element    -   28 Anatomical interface component    -   30 Light source    -   32 Speaker    -   34 Microphone    -   36 Diaphragm    -   38 Kit    -   40 Oral device    -   42 Light emitting    -   44 Battery

What is claimed is:
 1. An imaging apparatus for obtaining images insidean ear canal of a patient's ear, the imaging apparatus comprising: amain body; a first anatomical interface component coupled to the mainbody, the first anatomical interface component structured to fit overthe patient's ear and contact the helix of the patient's ear; anextension coupled to the main body, the extension structured to fit intothe ear canal; and an imaging element housed within the extension, theimaging element configured to obtain an image of the ear canal.
 2. Theimaging apparatus of claim 1, wherein the extension is flexible.
 3. Theimaging apparatus of claim 1, wherein the extension is extendable. 4.The imaging apparatus of claim 1, further comprising a second anatomicalinterface coupled to the main body, the second anatomical interfacecomprising a stop structured to contact the outer ear to preventover-insertion of the extension into the ear canal.
 5. The imagingapparatus of claim 4, wherein the second anatomical interface furthercomprises an ear bud.
 6. The imaging apparatus of claim 1, wherein theextension comprises a spring to prevent over-insertion of the extensioninto the ear canal.
 7. The imaging apparatus of claim 1, wherein theextension comprises a channel for air to flow through the extension. 8.The imaging apparatus of claim 1, wherein the extension comprises alight output at a tip of the extension.
 9. The imaging apparatus ofclaim 8, wherein the light output is coupled to a light source locatedin the one of the anatomical interface element, the extension, or themain body.
 10. The imaging apparatus of claim 1, wherein a center of alens of the imaging element is offset from a central axis of theextension at a tip of the extension.
 11. The imaging apparatus of claim1, further comprising a communication link communicatively coupling theimaging apparatus to a processor.
 12. The imaging apparatus of claim 11,wherein the processor is located separate from the imaging apparatus.13. The imaging apparatus of claim 11, wherein the processor iscommunicatively coupled to one of a smartphone, tablet, or laptop.
 14. Akit for obtaining images inside an ear canal of a patient's ear, the kitcomprising: an imaging apparatus comprising: a main body; an anatomicalinterface component coupled to the main body, the anatomical interfacecomponent structured to fit over the patient's ear and contact the helixof the patient's ear; a first extension coupled to the main body, thefirst extension structured to fit into the ear canal; and an imagingelement housed within the first extension, the imaging elementconfigured to obtain an image of the ear canal; and a plurality ofattachments, each attachment: configured to connect to the imagingapparatus; shaped to contact the outer ear; and sized to fit arespective ear size.
 15. The kit of claim 14, wherein the firstextension is flexible.
 16. The kit of claim 14, wherein the plurality ofattachments are earbuds, each earbud comprising a stop structured tocontact the outer ear to prevent over-insertion of the first extensioninto the ear canal.
 17. The kit of claim 16, wherein each earbud furthercomprises a second extension structured to fit into the ear canal. 18.The kit of claim 14, wherein the first extension comprises a channel forair to flow through the first extension.
 19. The kit of claim 14,wherein the first extension is extendable.
 20. The kit of claim 14,further comprising: a processing box configured to receive, from theimaging apparatus, the image of the ear canal; and a communicationdevice communicatively coupled to the processing box over a wirelesscommunication link, wherein the communication device is one of asmartphone, tablet, or laptop.